Iovance Biotherapeutics was Granted Fast Track Designation for LN-145 for Cervical Cancer
February 26 2019 - 7:00AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation for LN-145 for the treatment of patients with
recurrent, metastatic or persistent cervical cancer who have
progressed while on or after chemotherapy. LN-145 is the Company’s
adoptive cell therapy produced using its proprietary TIL
manufacturing technology.
“We are pleased to have received Fast Track designation for
LN-145 for the treatment of cervical cancer in patients who have
failed chemotherapy treatment,” commented Maria Fardis, Ph.D., MBA,
president and chief executive officer of Iovance Biotherapeutics.
“The designation is an important positive step for the development
of LN-145 in a serious and unmet medical need patient population.
We are excited about the clinical data for LN-145 in cervical
cancer patients and look forward to a closer collaboration with
the FDA as we advance the clinical development of LN-145
for the treatment of cervical cancer.”
The Fast Track designation from the FDA is designed to
facilitate the development and expedite the review of drugs to
treat serious conditions and fill an unmet medical need, which
includes providing a therapy that may be potentially better than
the available ones. With the Fast Track designation for
LN-145, Iovance is expected to have more frequent meetings and
communication with the FDA and is eligible, if relevant criteria
are met upon submission, for a Rolling Review of the Biologic
License Application (BLA) and potentially Accelerated
Approval.1
The Company had previously reported preliminary data from the
Phase 2 study of LN-145 for cervical cancer (C-145-04) in October
2018 for 15 patients yielding an overall response rate (ORR) of
27%. Patients in the study had a median of five prior therapies.
The most common treatment-emergent adverse events included chills,
pyrexia and anaemia. The protocol for the cervical cancer study has
since been amended to limit the number of prior therapies to no
more than three and to exclude patients who have been treated with
prior immunotherapy. The study is actively recruiting patients at
32 clinical sites in the United States and Europe. The company
anticipates providing an update on this study at an upcoming
medical meeting in 2019.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is a clinical-stage
biotechnology company focused on the development of cancer
immunotherapy products for the treatment of various cancers. The
company's lead product candidate is an adoptive cell therapy using
TIL technology being investigated for the treatment of patients
with metastatic melanoma, recurrent and/or metastatic squamous cell
carcinoma of the head and neck, recurrent, metastatic or persistent
cervical cancer and locally advanced or metastatic non-small cell
lung cancer. For more information, please
visit www.iovance.com.
Forward-Looking Statements
Certain matters discussed in this press release are
“forward-looking statements” of Iovance Biotherapeutics, Inc.
(hereinafter referred to as the “Company,” “we,” “us,” or “our”).
We may, in some cases, use terms such as “predicts,” “believes,”
“potential,” “continue,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. The forward-looking
statements include, but are not limited to, risks and uncertainties
relating to the success, timing, projected enrollment,
manufacturing capabilities, and cost of our ongoing clinical trials
and anticipated clinical trials for our current product candidates
(including both Company-sponsored and collaborator-sponsored trials
in both the U.S. and Europe), such as statements regarding the
timing of initiation and completion of these trials; the timing of
and our ability to obtain and maintain U.S. Food and Drug
Administration or other regulatory authority approval of, or other
action with respect to, our product candidates; the strength of
Company’s product pipeline; the successful implementation of the
Company’s research and development programs and collaborations; the
success of the Company’s manufacturing, license or development
agreements; the acceptance by the market of the Company’s product
candidates, if approved; and other factors, including general
economic conditions and regulatory developments, not within the
Company’s control. The factors discussed herein could cause actual
results and developments to be materially different from those
expressed in or implied by such statements. Actual results
may differ from those set forth in this press release due to the
risks and uncertainties inherent in the Company’s business,
including, without limitation: the preliminary clinical results,
including efficacy and safety results, from ongoing Phase 2 studies
may not be reflected in the final analyses of these trials,
including new cohorts within these trials, and may not be
supportive of product approval; the FDA or other regulatory
authorities may potentially delay the timing of their approval of,
or other action with respect to, the Company’s product candidates
(specifically, the Company’s description of FDA interactions are
subject to FDA’s interpretation, as well as FDA’s authority to
request new or additional information); the Company’s ability to
address FDA or other regulatory authority requirements relating to
its clinical programs and registrational plans, such requirements
including, but not limited to, clinical and safety requirements as
well as manufacturing and control requirements; risks related to
the Company’s accelerated FDA review designations; and the ability
of the Company to manufacture its therapies using third party
manufacturers. A further list and description of the
Company’s risks, uncertainties and other factors can be found in
the Company’s most recent Annual Report on Form 10-K and the
Company's subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at
www.sec.gov or www.iovance.com. The forward-looking statements are
made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
Investor Relations Contacts: Annie
ChangSolebury Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Media Relations Contact: Rich AllanSolebury
Trout646-378-2958rallan@troutgroup.com
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https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm
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